Skip to main content
OpenTrials
Completed

NCT Number: NCT05308940

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 in Healthy Subjects

It was a randomized, double-blind, placebo-controlled combined single ascending dose (SAD) and multiple ascending dose (MAD) study, evaluating the safety, tolerability and pharmacokinetics of TB001 after single and multiple subcutaneous injections in healthy subjects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shenzhen Turier Biotech Co., Ltd.

Shenzhen, Guangdong, 518122, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written and signed informed consent.
  • Aged 18-55 years (inclusive), male or female.
  • BMI within 18.0-28.0 kg/m2 (inclusive).
  • Have physically and psychologically health judged by the investigator based on the medical history, physical examination, laboratory evaluation, electrocardiogram, etc.
  • Have agreed to take effective contraception measures.

Exclusion criteria

  • Have any prior clinically serious disease of any system.
  • Known or suspected allergy to the study drug or any of its ingredients.
  • Severe infection, severe trauma or major surgical operation within 3 months prior to the first administration.
  • History of recurrent or chronic infection within 6 months prior to the first administration.
  • Unable to comply with dietary management during the study period.
  • Pregnant or lactating women.

Treatment and study plan

TB001

Drug

once-daily subcutaneous injection, on Day 1 in SAD stage

Placebo

Drug

once-daily subcutaneous injection, on Day 1 in SAD stage

Primary outcomes

  1. Incidence and severity of adverse events (AEs)

    Time frame: Day 1 and up to Day 28

    An AE is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship.

Secondary outcomes

  1. Pharmacokinetics exposure of TB001 in SAD and MAD stage

    Time frame: Day 1 , Day 7

    Serum concentrations of TB001 at different timepoints before and after TB001 administration.

  2. Observed immunogenicity of TB001 in MAD stage

    Time frame: Day 1, Day 7, Day 14, Day 28

    Number of subjects who develop detectable ADAs and NAb after TB001 administration.

Sponsors and collaborators

Lead sponsor

Shenzhen Turier Biotech Co., Ltd

Other

Registry information

Official study title

A Phase 1, Single and Multiple Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 Injection in Healthy Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2022
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.